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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029184
Receipt No. R000033366
Scientific Title Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Date of disclosure of the study information 2017/09/19
Last modified on 2019/04/23

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Basic information
Public title Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Acronym Stress check study
Scientific Title Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Scientific Title:Acronym Stress check study
Region
Japan

Condition
Condition subthreshold depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and efficacy of the internet-based guided self-help cognitive behavioral therapy with subthreshold depression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The Center for Epidemiological Studies Depression scale (CES-D)
Key secondary outcomes 1. Beck Depression Inventory-II (BDI-II)
2. General Health Questionnaire-12 (GHQ12)
3. QOL (EQ-5D-5L)
4. Sheehan Disability Scale (SDISS)
5. Presenteeism (Stanford Presenteeism Scale (SPS)
6. Cognitive Control Scale
7. Quick Inventory of Depressive Symptomatology (QIDS-J)
8. Session Rating Scale (SRS)
9. Onset of depressive disorders at the 36 weeks follow-up

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Internet-based guided self-help cognitive behavioral therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
66 years-old >
Gender Male and Female
Key inclusion criteria 1. Workers with high stress-related symptoms and conditions assessed by the Stress Check Test
2. The Center for Epidemiological Studies-Depression (CES-D) > = 16 at the baseline
3. Age 20 years or older, and 65 years or younger at the baseline
4. Subjects who give full consent in the participation of the study
Key exclusion criteria 1. Subjects with current DSM-IV major depressive disorder or during treatment for depression at the baseline
2. Subjects with manic episode or psychotic disorders or during treatment for bipolar disorder or psychotic disorders at the baseline
3. During treatment with antidepressant, mood stabilizer or antipsychotics at the baseline
4. Serious suicidal ideation at the baseline
5. Structured psychotherapy during the intervention
6. Other relevant reason decided by the investigators
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Reiji
Middle name
Last name Yoshimura
Organization University of Occupational and Environmental Health, Japan
Division name Department of Psychiatry
Zip code 807-0804
Address 1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL 093-691-7253
Email yoshi621@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name Utsunomiya
Organization University of Occupational and Environmental Health, Japan
Division name Department of Psychiatry
Zip code 807-0804
Address 1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL 093-691-7253
Homepage URL
Email k-utsu@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Keio University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Occupational and Environmental Health, Japan
Address 1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
Tel 093-691-7205
Email daigakukanri@mbox.pub.uoeh-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 25 Day
Date of IRB
2017 Year 09 Month 05 Day
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 19 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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